Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps (NCT06807073) | Clinical Trial Compass
RecruitingNot Applicable
Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps
Canada686 participantsStarted 2025-02
Plain-language summary
The goal of this clinical trial is to compare adverse even rates after EMR for large (≥20mm) flat colorectal polyps (so-called laterally spreading lesions, LSLs) when performing complete or no defect closure. It will also evaluate lesion recurrence after EMR for large colorectal LSLs.
The hypothesis is that performing complete defect closure following EMR of large colorectal LSLs will result in lower rates of adverse events compared to cases where no defect closure is performed.
For participants with planned EMR, endoscopists will perform EMRs as per standard of care and:
* prophylactic defect closure will either not be performed (control group), or will be performed (experimental group);
* then, patients will be called between 14 and 44 days after EMR to assess for possible adverse events, and electronic medical files will be verified for emergency room visits and healthcare received for an adverse event;
* finally, patients will undergo follow-up colonoscopy 6 months and 18 months after randomization.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* adult ≥18 years old
* patients undergoing EMR for a large (≥20mm) colorectal LSL
* patients providing written and informed consent for study participation.
Exclusion Criteria:
* inflammatory bowel disease;
* non-elective colonoscopy;
* poor general health (American Society of Anesthesiologists classification \>III);
* coagulopathy or thrombocytopenia (international normalized ratio ≥1.5 or platelets \<50 x 109/L);
* pedunculated polyps (Paris class Ip, Isp);
* overt signs of deep submucosal invasive cancer (JNET 3);
* appendiceal orifice or terminal ileum invasion;
* pregnancy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Delayed bleeding
Timeframe: 14 days
2
Delayed perforation
Timeframe: 14 days
Trial details
NCT IDNCT06807073
SponsorCentre hospitalier de l'Université de Montréal (CHUM)